Prospective, Observational Survey Study Assessing Effectiveness of Zuranolone in Improving PPD Symptoms in the Real-world Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 305
- 试验地点
- 2
- 主要终点
- Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) at Day 15
研究概览
简要总结
In this study, researchers will learn more about how zuranolone affects the symptoms of postpartum depression, also known as PPD. Zuranolone is a drug that healthcare professionals can prescribe for adults with PPD. After giving birth, adults with PPD can suffer from symptoms such as tiredness, sadness, and a loss of interest in their daily activities.
This study is known as an observational study, which means it collects health information about study participants after a healthcare professional has already prescribed treatment. Participants for this study will be found in the United States using a database from Consumer Value Store (CVS) Specialty Pharmacy. This will include anyone who was prescribed zuranolone between June 2025 and May 2026 and who filled the prescription within 1 year after the end of their pregnancy.
The main goal of this study is to learn more about how zuranolone affects the participants' PPD symptoms. This will be measured using a questionnaire completed by participants called the Edinburgh Postnatal Depression Scale, also known as the EPDS. A higher score on the EPDS may indicate more severe PPD symptoms.
The main question researchers want to answer in this study is:
- Do PPD symptoms change after treatment with zuranolone based on EPDS scores measured at Day 15?
Researchers will also learn more about:
- Changes in participants' EPDS scores from before treatment to Day 3, Day 45, and Day 90, which is 30 days after treatment ends.
- How many participants breastfeed their babies while taking zuranolone
- How many participants do not start new medicine after finishing their zuranolone treatment
- How many participants take new medicines after finishing zuranolone
- How many participants already tried other medicines for their depression symptoms before joining this study
- How many participants take other medicines in general while taking zuranolone
- Characteristics of participants' treatment use during the study
This study will be done as follows:
- People who fill their zuranolone prescription through CVS Specialty Pharmacy will be contacted by email or phone to ask them about their interest in participating in the study.
- Those who agree to take part will answer written questions about their symptoms using the EPDS tool. They will also answer other survey questions about their background, environment, and general health information. Participants must take their first dose of zuranolone within 7 days of joining the study.
- Participants will then be asked to answer questions using the EPDS tools, 3 days, 15 days, 45 days, and 90 days after taking the first dose of zuranolone.
详细描述
The primary objective of this study is to assess the effectiveness of zuranolone in reducing postpartum depression (PPD) symptoms via the Edinburgh Postnatal Depression Scale (EPDS) at Day 15. The secondary objectives are to assess the effectiveness of zuranolone in reducing PPD symptoms via the EPDS at Day 3, Day 45 and Day 90, to assess changes in EPDS score at day 3 among participants initiating zuranolone prior to day 0 completion versus those initiating zuranolone after/same day as day 0 completion, to assess breastfeeding status during treatment with zuranolone at Day 45 and to characterize treatment usage across the 90-day period via self-reported survey questions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adults who were prescribed and had one successful fill for zuranolone within 12 months following end of pregnancy for the treatment of PPD from March 2026 to July 2026 through CVS Specialty Pharmacy.
- •Currently reside in the United States.
- •Able to complete the questionnaires independently.
排除标准
- •Prior fill of zuranolone or brexanolone in last 12 months.
- •Participants with 2 or more doses of zuranolone at the time of screening.
- •Current or history of bipolar disorder.
- •Failure to complete baseline surveys prior to 2nd dose of zuranolone.
- •Pregnancy that ended more than 12 months ago.
- •Other protocol-defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Cohort 1
Participants who are prescribed zuranolone for PPD and are filling zuranolone through a CVS specialty pharmacy will be contacted through email or the call center for enrollment in the study. Participants will complete 3 study visits: Day 0, Day 15, and Day 45.
干预措施: Zuranolone (Drug)
Cohort 2
Participants who are prescribed zuranolone for PPD and are filling zuranolone through a CVS specialty pharmacy will be contacted through email or the call center for enrollment in the study. Participants will complete 5 study visits: Day 0, Day 3, Day 15, Day 45, and Day 90.
干预措施: Zuranolone (Drug)
结局指标
主要结局
Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) at Day 15
时间窗: Baseline (Day 0), Day 15
EPDS is a 10-item self-report questionnaire used for the assessment of PPD symptoms. Each item is scored from 0-3, with a total score range of 0-30. Higher scores indicate more severe depressive symptoms.
Cohorts 1 and 2: Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) at Day 15
时间窗: Baseline (Day 0), Day 15
EPDS is a 10-item self-report questionnaire used for the assessment of PPD symptoms. Each item is scored from 0-3, with a total score range of 0-30. Higher scores indicate more severe depressive symptoms.
次要结局
- Change From Baseline in EPDS at Day 45(Baseline (Day 0), Day 45)
- Number of Participants That Self-Report no New Initiation of Medication After Completion of Zuranolone(Day 45)
- Number of Participants With Moderate PPD Severity That Self-Report no New Initiation of Medication After Completion of Zuranolone(Day 45)
- Number of Participants That Self-Report Feeding Their Baby Breastmilk as Usual While Taking Zuranolone(Day 45)
- Number of Participants That Self-Report History of Medication Use for Depression(Day 0)
- Number of Participants With Moderate PPD Severity That Self-Report History of Medication Use for Depression(Day 0)
- Number of Participants With Moderate PPD Severity That Self-Report Prior Lines of Treatment for Their Current PPD Episode(Day 0)
- Change From Baseline in EPDS in Participants With Moderate Postpartum Depression (PPD) Severity at Days 15 and 45(Baseline (Day 0), Days 15 and 45)
- Number of Participants That Self-Report Prior Lines of Treatment for Their Current PPD Episode(Day 0)
- Number of Participants With Moderate PPD Severity That Self-Report Concomitant Medication Use With Zuranolone for the Treatment of PPD(Day 0)
- Number of Participants That Self-Report Concomitant Medication Use With Zuranolone for the Treatment of PPD(Day 0)
- Cohorts 1 and 2: Change From Baseline in EPDS Score(Baseline (Day 0), Days 3 (Cohort 2 only), 45 and 90 (Cohort 2 only))
- Cohorts 1 and 2: Change From Baseline in EPDS in Participants With Moderate Postpartum Depression (PPD) Severity at Days 15 and 45(Baseline (Day 0), Days 15 and 45)
- Cohorts 1 and 2: Change From Baseline in EPDS by Baseline Severity(Baseline (Day 0) up to Day 45 (Cohort 1, up to Day 90 (Cohort 2))
- Cohorts 1 and 2: Number of Participants Achieving Remission(At Days 15, 45 and 90 (Cohort 2 only))
- Cohort 2: Change From Baseline on the EPDS at Day 3 Among Participants Initiating Zuranolone Prior to Day 0 Completion(Baseline (Day 0), At Day 3)
- Cohort 2: Change From Baseline on the EPDS at Day 3 Among Participants Initiating Zuranolone After/Same day as Day 0 Completion(Baseline (Day 0), At Day 3)
- Cohorts 1 and 2: Percentage of Participants That Self-Report no New Initiation of Medication After Completion of Zuranolone(At Days 45 and 90 (Cohort 2 only))
- Cohorts 1 and 2: Number of Participants That Self-Report Feeding Their Baby Breastmilk as Usual While Taking Zuranolone(Day 45)